Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002816
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
EXTRAMEDULLARY RELAPSE AND OCCULT BONE MARROW INVOLVEMENT IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA A PHASE III GROUP-WIDE STUDY
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia
PURPOSE Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES I Improve the outcome in children with first isolated central nervous system CNS testicular or ocular relapse of acute lymphoblastic lymphoma ALL and increase the knowledge of the characteristics of extramedullary and subsequent relapses of ALL II Quantitate by current molecular biologic techniques occult systemic leukemia in cases of conventional isolated extramedullary relapse and examine the relationship between this assessment and subsequent clinical outcome particularly overt marrow relapse III Quantitate occult systemic leukemia in subsets of extramedullary relapse that include site CNS testis or eye time of relapse early or late initial risk group immunophenotype DNA index and karyotype gender for CNS and eye and ethnicity and assess the response to therapy in patients entered on companion protocol CCG-B958 IV Compare the relative sensitivities of two quantitative in vitro assays for occult systemic leukemia fluorescence-activated cell sorterleukemic progenitor cell clonogenic assay vs polymerase chain reaction-based clonospecific assay correlate the assays with clinical outcome and assess other biologic studies of leukemic cells eg neurotropic potential in the SCID mouse xenograft model and methotrexate sensitivity V Determine the event-free survival EFS and pattern of failure in children with first isolated CNS testicular or ocular relapse after treatment that includes intensive systemic chemotherapy VI Correlate EFS in patients with CNS and ocular relapse with sex and in patients with relapse at all three sites with ethnicity VII Evaluate the impact of combined chemotherapy and radiotherapy on health status in survivors at two and four years after extramedullary relapse and study entry
OUTLINE All patients receive induction chemotherapy over 5 weeks with etoposide ifosfamidemesna dexamethasone vincristine and pegaspargase if pegaspargase is not available E coli asparaginase may be substituted throughout study then dexamethasone vincristine pegaspargase or E coli asparaginase and high-dose methotrexate with leucovorin rescue and triple intrathecal chemotherapy TIT Following induction chemotherapy all patients receive two 6-week courses of intensification therapy with intermittent TIT each course consists of dexamethasone vincristine high-dose methotrexateleucovorin thioguanine cytarabine etoposide and pegaspargase or E coli asparaginase followed by dexamethasone vincristine high-dose methotrexateleucovorin thioguanine ifosfamidemesna and idarubicin Patients receive 2 additional courses of intensification chemotherapy followed by four 12-week courses of maintenance chemotherapy with vincristine and methotrexate every 2 weeks and daily oral thioguanine Total duration of therapy is 78 weeks Patients with isolated ocular relapse receive local radiotherapy prior to initiation of induction chemotherapy those who also have CNS leukemia begin TIT with the radiotherapy Patients with CNS relapse receive craniospinal irradiation during the first month of maintenance therapy with the dose and fields based on whether they will receive TBI and whether they have had CNS irradiation previously Patients with testicular relapse receive bilateral testicular irradiation during the first 3 weeks of intensification therapy Patients are followed every 3 months for 3 years every 6 months for 3 years and yearly thereafter or upon relapse second malignancy loss to follow up or death All patients undergo quality-of-life assessment at entry and 2 and 4 years after entry
PROJECTED ACCRUAL Approximately 120 patients will be accrued for this study
OUTLINE All patients receive induction chemotherapy over 5 weeks with etoposide ifosfamidemesna dexamethasone vincristine and pegaspargase if pegaspargase is not available E coli asparaginase may be substituted throughout study then dexamethasone vincristine pegaspargase or E coli asparaginase and high-dose methotrexate with leucovorin rescue and triple intrathecal chemotherapy TIT Following induction chemotherapy all patients receive two 6-week courses of intensification therapy with intermittent TIT each course consists of dexamethasone vincristine high-dose methotrexateleucovorin thioguanine cytarabine etoposide and pegaspargase or E coli asparaginase followed by dexamethasone vincristine high-dose methotrexateleucovorin thioguanine ifosfamidemesna and idarubicin Patients receive 2 additional courses of intensification chemotherapy followed by four 12-week courses of maintenance chemotherapy with vincristine and methotrexate every 2 weeks and daily oral thioguanine Total duration of therapy is 78 weeks Patients with isolated ocular relapse receive local radiotherapy prior to initiation of induction chemotherapy those who also have CNS leukemia begin TIT with the radiotherapy Patients with CNS relapse receive craniospinal irradiation during the first month of maintenance therapy with the dose and fields based on whether they will receive TBI and whether they have had CNS irradiation previously Patients with testicular relapse receive bilateral testicular irradiation during the first 3 weeks of intensification therapy Patients are followed every 3 months for 3 years every 6 months for 3 years and yearly thereafter or upon relapse second malignancy loss to follow up or death All patients undergo quality-of-life assessment at entry and 2 and 4 years after entry
PROJECTED ACCRUAL Approximately 120 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCG-1951 | OTHER | None | None |
| CDR0000064968 | OTHER | Clinical Trialsgov | None |